An interview with Ann Becker Schutte, Ph.D Last year, for the first time, I attended Stanford...READ MORE
Could It Get Any Worse? An Update on Transvaginal Mesh Lawsuits
Many people who visit this blog are already aware that transvaginal mesh was never tested on humans for vaginal use before it entered the market; instead transvaginal mesh was cleared by the FDA and allowed to enter the market because of the FDA’s 501(K) system which permits devices to be sold without human testing so long as the device is determined to be similar to products already for sale. (We will post a blog soon that details this approval process more.) In the case of transvaginal mesh, the device was approved based on its similarity to a hernia repair mesh – a device used for an entirely different purpose. In fact, the only real similarities between the two are the mesh they used – and that’s another problem. You see, some of the mesh product that Bard used for both products was a resin-based plastic made by Chevron Phillips Chemical Co, and was never intended for permanent use within the body.
In 2007, Chevron Phillips Chemical Co. filed a mandatory safety date report, titled “Material Safety Data Sheet,” with the U.S. Occupational Safety and Health Administration (OSHA) explaining that this resin plastic, a marlex propylene, should not be used in medical applications that require permanent placement within the human body. (http://www.bloomberg.com/news/2013-06-26/bard-used-mesh-plastic-found-unfit-for-humans-by-supplier.html)
The problem is not that Bard was not aware of this danger; it is that they apparently chose not to listen.
In fact, Roger Darois, then an executive with Bard’s unit responsible for making the transvaginal mesh device and now vice president of Bard, wrote in an email sent in March 2004: “it is likely that they do not know of our implant application. Please do not mention Davol’s name in any discussion with these manufacturers.”
Why would Bard’s Davol unit not want to disclose that they were using this plastic in an unauthorized, dangerous application? Because with the transvaginal application, the mesh was most likely to degrade and shrink, causing bleeding and organ damage to the patient –and that would have hurt Bard’s bottom line. But if Bard did not take patient’s’ health and safety seriously, who did? The answer is devastating: No one did, as no one knew.
To participate in a lawsuit against mesh manufacturers for transvaginal mesh complications, give us a call at 1.866.472.9108 today. Our transvaginal mesh lawyers will offer you a free and confidential consultation to determine if you qualify for a transvaginal mesh lawsuit.